Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the New Drug Application (NDA) for picankibart injection, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, has been accepted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of moderate to severe plaque psoriasis. Picankibart is the first IL-23p19 antibody drug to show over 80% of subjects achieving PASI 90 after 16 weeks of treatment in a registrational Phase 3 clinical trial. It also offers the longest maintenance dosing interval (once every 12 weeks) among the same class of biologics. Picankibart is expected to deliver comprehensive benefits, including skin lesion clearance, improved medication convenience and enhanced quality of life for Chinese patients with moderate to severe plaque psoriasis.

This NDA acceptance is based on positive results from the Phase 3 registrational clinical study CLEAR-1 (NCT05645627) in Chinese patients with moderate to severe plaque psoriasis. The study successfully met its primary and all key secondary endpoints in May 2024, showing significantly higher rates of skin lesion clearance (PASI 90, PASI 75, PASI 100, sPGA 0/1, and sPGA 0) and quality of life improvement (DLQI 0/1) in the picankibart group compared to placebo. Picankibart showed a favorable safety profile, with no new safety signals. Detailed data from the CLEAR-1 study will be presented at future academic conferences and published in academic journals.